Intica Neo 7 VR-T DX DF-1 ProMRI 429559Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BIOTRONIK Intica Neo 7 VR-T DX DF-1 ProMRI is an implanted defibrillator placed under the skin to treat abnormal heart rhythms. The 30 reports mostly describe the unit being removed because of infection at or near the implant site, including wound healing problems and bloodstream infection; 20 reports describe injuries and 1 death. Smaller numbers mention unexpected battery behavior and high impedance on the lead. No recalls name this device, and reports have risen only slightly in the past year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 1
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04035479156855), received between Dec 14, 2020 and Sep 29, 2026 — classified as 1 death, 22 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem21
- Battery Problem3
- High impedance3
- Device Sensing Problem2
- Ambient Noise Problem1
- Connection Problem1
- Device Damaged by Another Device1
- Failure to Interrogate1
Patient problems
- Unspecified Infection18
- No Clinical Signs, Symptoms or Conditions10
- Tachycardia2
- Bacteremia1
- Discomfort1
- Sepsis1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50926763 ↗InjurySep 24, 2026Failure to Interrogate; Device Damaged by Another Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892043 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to bacteremia infection. Should additional information become available, this file will be updated.
Patient problems: Bacteremia
MAUDE report 50430654 ↗InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to possible infection from non-healing wound. Should additional information be received, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50230236 ↗InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED AND LEAD WAS CAPPED DUE TO INFECTION AND PT SEPTIC. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 25727708 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25137174 ↗InjuryMay 3, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25064111 ↗InjuryApr 16, 2026High impedance; Connection Problem
ONE WEEK AFTER IMPLANT THIS DEVICE WAS EXPLANTED. BEFORE REMOVING THE DEVICE, THEY REMOVED AND INSERTED THE SHOCK COIL LEAD SEVERAL TIMES AND EVERY TIME THE IMPEDANCE WAS GREATER THAN 150. IT IS SUSPECTED THERE MAY BE AN ISSUE WITH THE SET SCREW. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24900025 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24567883 ↗MalfunctionJan 15, 2026Battery Problem
THIS DEVICE SHOWS UNEXPECTED BATTERY BEHAVIOR. DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24079676 ↗InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22866009 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO POCKET INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22030820 ↗InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22019960 ↗MalfunctionFeb 18, 2025Ambient Noise Problem; Ambient Noise Problem
CLINICIAN REPORTS THE DEVICE RECORDS RECURRENT 5 MINUTE EPISODES OF NOISE ON THE ATRIAL CHANNEL AS AT RECORDINGS AT EXACT 1 HOUR INTERVALS AND STATES THEY HAVE RULED OUT ALL POSSIBLE SOURCES OF EMI. CLINICIAN BELIEVES THIS IS AN ISSUE WITH THE DEVICE AND NOT ENVIRONMENTAL. RAM DOWNLOAD ATTACHED. DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21405699 ↗MalfunctionFeb 6, 2025High impedance; Misconnection; High impedance; Misconnection
THIS DEVICE HAD AN ALERT FOR GREATER THAN 150 SHOCK IMPEDANCE AT IMPLANT FOLLOW-UP. A PIN CONNECTER/HEADER ISSUE WAS SUSPECTED. AT (B)(6) 2025 REVISION PROCEDURE, THEY FOUND THE DF1 CONNECTOR PIN LEG WAS LOOSE IN POCKET. THIS WAS RECONNECTED AND ALL TESTING NORMAL. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21321386 ↗InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 19305134 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 19000364 ↗DeathDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2023, THE PATIENT HAD A FEW NON-SUSTAINED TACHYCARDIA EPISODES AS WELL AS ONE THERAPY ZONE EPISODE THAT WAS CLASSIFIED AS AN SVT (NO THERAPY PROVIDED BY DEVICE) WHILE THE EPISODE SHOWED WHAT APPEARED TO BE A TRUE VT WHERE THERAPY WAS DESIRED. THE DEVICE APPEARS TO HAVE PERFORMED ACCORDING TO THE PROGRAMMING GIVEN THE THERAPY ZONES CUTOFFS AND SMART DETECTION IN DX DEVICES WITH THE ONSET AND STABILITY VALUES OF THE PRESENTING RHYTHM. THE PATIENT WAS REPORTED TO HAVE PASSED AWAY AFTER THESE EPISODES AT AN UNKNOWN DATE AND TIME.
Patient problems: Tachycardia
MAUDE report 18271952 ↗MalfunctionOct 30, 2023High impedance; High impedance
SHOCK IMPEDANCE OUT OF RANGE POST GENERATOR CHANGE. IT FIRST APPEARED OUT OF RANGE ON (B)(6) 2023, AND INTERMITTENTLY PRESENTS IN RANGE VALUES. HOWEVER, THE MAJORITY OF THE TIME IT IS OUT OF RANGE GREATER THAN 150 OHMS. PATIENT WAS BROUGHT INTO OFFICE AND THE PATHWAY RV TO CAN WAS TESTED INDEPENDENTLY OF RV TO SVC. IN OFFICE MEASUREMENTS WERE NORMAL IN BOTH PATHWAYS. HOWEVER, IT STILL PRESENTS AS OUT OF RANGE ON HOME MONITORING. IT WAS NOT DETERMINED IN OFFICE IF THE PROBLEM IS IN THE PATCH OR THE LEAD OR EVEN THE NEW GENERATOR AT THE PIN CONNECTION IN THE HEADER. PHYSICIAN DECISION AS TO NEXT STEPS AND CURRENTLY ALL REMAIN IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18030557 ↗InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 17585290 ↗InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 17152848 ↗InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 17106582 ↗InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 16864678 ↗InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 16406284 ↗InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO PATIENT NO LONGER WANTED THE SYSTEM DUE TO DISCOMFORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Discomfort
MAUDE report 16342851 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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